EP2961463B1 - Ballonkatheter - Google Patents

Ballonkatheter Download PDF

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Publication number
EP2961463B1
EP2961463B1 EP14705255.9A EP14705255A EP2961463B1 EP 2961463 B1 EP2961463 B1 EP 2961463B1 EP 14705255 A EP14705255 A EP 14705255A EP 2961463 B1 EP2961463 B1 EP 2961463B1
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EP
European Patent Office
Prior art keywords
balloon
catheter
distal end
inflatable balloon
inflatable
Prior art date
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EP14705255.9A
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English (en)
French (fr)
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EP2961463A1 (de
Inventor
Steen Aggerholm
Thomas Lysgaard
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Cook Medical Technologies LLC
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Cook Medical Technologies LLC
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Publication of EP2961463A1 publication Critical patent/EP2961463A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A61M2210/1082—Kidney

Definitions

  • the present invention relates generally to medical devices and more particularly to balloon catheters used to treat narrowed or obstructed portions of a body vessel. Certain aspects of the invention relate to methods of manufacturing such devices.
  • Balloon catheters are widely used in the medical profession for various intraluminal procedures.
  • One common procedure relates to the dilation of an obstructed portion of a body vessel.
  • certain body ducts that transport fluids are subject to obstruction by solid masses, or "stones", formed from crystals that separate from the transported fluid and build up within the duct.
  • stones include renal stones, gall stones and gastric stones.
  • stones that cause lasting symptoms or other complications require intervention to remove the stones from the body.
  • Renal stones are one of the most painful of urologic disorders. Such stones form within the kidney from crystals that separate from urine. Sometimes, such stones travel down the urinary tract and are expelled from the body. In other cases, a stone may cause a blockage in the urinary tract.
  • Narrow tubes called ureters carry urine from the kidneys to the bladder.
  • the bladder stores urine and eventually empties the urine into the urethra, from which it is expelled from the body.
  • Renal stones may form in the ureters and can contain various combinations of chemicals.
  • One type of stone contains calcium in combination with either oxalate or phosphate.
  • Another type of stone is formed from uric acid.
  • Gallstones are hard masses that form in the gallbladder, a sac-like organ under the liver on the right side of the abdomen. Such masses can obstruct the bile duct, a narrow tube connecting the gallbladder to the small intestine.
  • Extracorporeal shock wave lithotripsy is a minimally invasive treatment for the treatment of renal and gallbladder stones.
  • ESWL Extracorporeal shock wave lithotripsy
  • ultrasonic sound waves that are created outside the body travel through the skin and body tissues until they hit the denser stones. The stones break down into smaller particles that can sometimes be expelled naturally from the body. Renal stones can also be removed using laser lithotripsy.
  • This technique involves the insertion of a probe into the renal track.
  • a cystoscope or ureteroscope is inserted into the patient's urethra, either directly or over a guide wire, and is advanced up the urinary tract to locate the target renal stone.
  • a thin fiberoptic is introduced into a channel of the endoscope and advanced until it comes into contact with the stone.
  • Light from a laser, for example, a holmium laser, is directed through the fiberoptic and the stone disintegrates or fragments.
  • a balloon catheter is typically used for opening the ureteral opening directly beneath the stone's location before patients undergo surgical treatment.
  • a balloon catheter is inserted into the vessel and advanced to the occluded region.
  • the balloon is then dilated by delivering a dilation fluid through a lumen present in the catheter shaft. Inflation of the balloon causes the exterior surface of the balloon to press against the wall of the body vessel and to expand the vessel.
  • an unfolding balloon catheter which may include an elongated shaft having a balloon that can be actuated within a body lumen to capture and retrieve an intravascular device.
  • the balloon may be configured to radially and/or axially expand when inflated, enveloping the intravascular device.
  • the balloon may be formed by folding the ends of a distensible member inwardly, and then bonding the ends of the distensible member to the elongated shaft to form an expandable sleeve.
  • US 4,243,040 discloses an extracting device useful for removing kidney stones, gall stones and other objects from human body passages comprising a thin tubular rubber sleeve having its proximal and distal ends connected to the distal ends of outer and inner flexible tubes insertable into the body passage.
  • the sleeve is inflatable by fluid pressure, supplied along the clearance space between the tubes to dilate the passage.
  • the distal end of the sleeve is turned inside out and, when the sleeve is inflated, forms a soft annular flaring convex portion bulging beyond the distal end of the inner tube for sealing engagement with the stone, which is captured by suction, applied through the inner tube.
  • Document EP 0 200 668 A2 discloses a balloon catheter according to the preamble of claim 1.
  • the present invention provides a balloon catheter as defined by the features of claim 1.
  • the balloon is compressed in a longitudinal direction when deflated and, upon inflation, the distal region of the balloon extends distally beyond the distal end of the catheter.
  • the catheter shaft includes an inflation lumen extending from its proximal end towards the distal end to an inflation port in fluid contact with the interior of the balloon.
  • the catheter shaft includes a second lumen, which is sized to accept a wire guide.
  • the distal end of the balloon has a generally flat surface perpendicular to a longitudinal axis of the inflatable balloon.
  • the balloon can include a nylon material.
  • Another aspect of the present invention provides a method of manufacturing a balloon catheter as defined by the features of claim 14.
  • the compression is such that, when the inflatable balloon is inflated, a distal region of the inflatable balloon moves distally to at least the distal end of the catheter shaft. In another embodiment, the distal region of the inflatable balloon moves distally beyond the distal end of the catheter shaft.
  • the term “implantable” refers to an ability of a medical device to be positioned at a location within a body, such as within a body vessel. Furthermore, the terms “implantation” and “implanted” refer to the positioning of a medical device at a location within a body, such as within a body vessel.
  • proximal and distal should be understood as being in the terms of a physician using the device.
  • distal means the portion of the device which is farthest from the physician and the term proximal means the portion of the device which is nearest to the physician.
  • body vessel means any body passage or lumen, including but not limited to vascular coronary or peripheral vessels, esophageal, intestinal, biliary, urethral and ureteral passages.
  • One aspect of the present invention provides balloon catheters having an inflatable balloon that extends distally to at least the distal end of the catheter shaft when the balloon is inflated (tipless balloon catheters.)
  • an implantable balloon catheter 100 including catheter shaft 102, only the distal portion of which is illustrated, and catheter balloon 104 mounted at the distal end of catheter shaft 102.
  • Catheter shaft 102 includes an internal lumen (not shown) extending from its proximal end to inflation port 106.
  • Inflation port 106 is in fluid contact with the interior of catheter balloon 104 and provides a means of inflating catheter balloon 104.
  • catheter shaft may also include a wire guide lumen (not shown) for use in the delivery of the balloon catheter.
  • Figure 1 shows catheter balloon 104 in a deflated configuration. Proximal end of catheter balloon 104 attaches to catheter shaft at position 110 and distal end of balloon 104 attaches to catheter shaft 102 at or near its distal end 108. The distance between attachment positions 108 and 110 is less than the length of catheter balloon 104. As a consequence, when deflated, catheter balloon 104 includes folded portions 112, formed as a result of the longitudinal compression of catheter balloon 102.
  • Figure 2 illustrates balloon catheter 100 with catheter balloon 104 in an inflated condition.
  • catheter balloon 104 As catheter balloon 104 is inflated the ends of the balloon extend outwards.
  • distal end 116 of catheter balloon 104 extends distally beyond the distal end 108 of catheter shaft 102 while proximal end 114 of catheter balloon 104 extends proximally.
  • folded portions 112 straighten until catheter balloon 104 is in a fully inflated configuration.
  • catheter balloon 104 is fully inflated, the distal end 116 of catheter balloon is positioned at or distally of the distal end 108 of catheter shaft 102. In this configuration, the distal end 108 of catheter shaft 102 does not obstruct the positioning of catheter balloon directly against an obstruction in a body vessel.
  • Such a balloon may be formed of any flexible material, such as a polyolefin, polyurethane, fluoropolymer, polyethylene, polytetrafluoroethylene (PTFE), latex, rubber, and mixtures of these materials.
  • the thickness of the wall of the balloon is approximately 0.0012 cm (0.0005 inch) thick.
  • the wall of the balloon can be of any appropriate thickness provided that the thickness does not compromise properties that are important for achieving optimum performance.
  • the balloon wall thickness is within the range of approximately 0.0012 cm to 0.003 cm (0.0005 inch to 0.0012) inch thick.
  • the balloon is made from a low or non-compliant material, such as for example, nylon or polyester.
  • a low or non-compliant balloon will increase in diameter by up to a maximum of about 5% of its normal diameter in response to increasing the pressure for inflating the balloon to between about 5 to 50 atmospheres.
  • the balloon may be made from a hybrid or highly compliant material where the diameter of the balloon may increase as much as about 40% during inflation.
  • the hybrid or highly compliant balloon may proportionally increase in diameter in response to increases in inflation pressure which may allow for fewer balloon sizes to be used to treat a wider range of vessel diameters.
  • the rated burst pressure (RBP) of the balloon is equal to or greater than about 1013, 1520, 2026, 2533, 3040, 3546, 4053, 4560 or 5066 kPa (10, 15, 20, 25, 30, 35, 40, 45 or 50 atmospheres).
  • RBP is the statistically-determined maximum pressure to which a balloon may be inflated without rupturing. There is a 95% confidence that 99.9% of the balloons will not burst at or below the RBP upon single inflation.
  • the balloon can be a reinforced balloon.
  • the balloon can be reinforced by incorporating a sleeve or other reinforcing member into or onto the balloon. Examples of such reinforced balloons and their methods of manufacture are disclosed in co-pending U.S. patent application serial number 13/784,028 to Aggerholm and Lysgaard .
  • a reinforcing member is wound around the balloon. At least one other reinforcing member may also be wound around the balloon at an angle that crosses the first reinforcing member. In other embodiments, the reinforcing member is at least partially embedded within a layer of the balloon wall.
  • the reinforcing member may be in the form of a woven or knitted mesh of threads, in which the warp and weft fibers may extend along the longitudinal and transverse axes of the balloon.
  • the reinforcing member can have other structures, including a coil extending helically along the balloon or a punctured or apertured sleeve of strengthening material, for instance.
  • the reinforcing member extends along the entire length of the balloon, including a generally cylindrical body portion of the balloon and the end portions either side of the body portion, preferably up to where the balloon is attached to the catheter.
  • the reinforcing member can be formed from a mesh of fibrous material and can be made of any suitable material including polymer, metal or metal alloy, natural fiber; one example being a polyamide such as nylon, ultra-high molecular weight polyethylene fiber such as DYNEEMATM, graft materials, suture materials and mixtures of at least two of these materials.
  • the reinforcing member can be attached to the balloon with an adhesive or by heat fusing the reinforcing member to the balloon wall.
  • the reinforcing member is incorporated at least partially into a layer of the balloon wall.
  • the reinforced balloon is formed by a reflow process as described in co-pending U.S. patent application serial number 13/784,028 to Aggerholm and Lysgaard .
  • the balloon may be formed from raw tubing, which in one embodiment is a co-extrusion of at least a first and a second layer.
  • the first, outer, layer is a layer of polymer material which eventually forms outer layer of the balloon.
  • the second layer forms an inner layer of the balloon.
  • one or more additional layers are present in the co-extrusion.
  • two or more separate layers of raw tubing, placed one inside the other, are used to form the balloon.
  • the balloon may be manufactured by placing the raw tubing in a mold as described in co-pending U.S. patent application serial number 13/784028 to Aggerholm and Lysgaard .
  • the reinforcing member if present, is positioned within the mold chamber prior to the insertion of the raw tubing.
  • the raw tubing is then placed in the mold and is held tightly at the ends of the mold chamber as the mold is heated and inflation pressure fed into the lumen of the innermost raw tubing, causing the raw tubing to expand radially outwardly.
  • the raw tubing is heated to a temperature sufficient to cause the outer layer to soften or melt.
  • the reinforcing member becomes embedded, at least partially, within the material of the outermost raw tubing and thereby eventually within the outer layer of the subsequently formed balloon.
  • the reinforcing member may be placed between two of these layers so that the reinforcing member is incorporated between these layers, or at least partially within a least one of these layers.
  • the inner layer(s) of the raw tubing will likewise expand and act to press the outer layer radially outwardly as the result of inflation pressure within the lumen of the innermost layer of raw tubing.
  • the mold is heated to a temperature sufficient to cause the inner layer(s) to soften or melt, and thereby bond together and with the outermost layer.
  • the balloon can hence be formed within the mold by a single step manufacturing process, in contrast to methods which require subsequent manufacture and assembly steps to form multiple layers and specifically also to attach further components to the formed balloon.
  • the temperature of the mold is subsequently raised to the heat set temperature of at least one of the layers of the balloon wall.
  • the material forming this layer is heated to its heat set temperature whilst it is stretched, for example by inflation within the mold, the material becomes fixed such that when inflation pressure is removed, the material maintains its size and form rather than returning to its pre-inflated size and form.
  • the catheter shaft of the balloon catheters disclosed herein includes one or more radiopaque and/or echogenic markers to assist in the positioning of the balloon within the body vessel of a patient.
  • the balloon is inflated with an inflation fluid including a contrast medium.
  • a radiopaque and/or an echogenic material is incorporated into the structure of the balloon.
  • balloons containing such materials and methods of their manufacture are described in U.S. Patent Publication Number US1013/0053770, published February 28, 2013, to Aggerholm , and in co-pending U.S. patent application serial number 13/784028 to Aggerholm and Lysgaard .
  • the balloon wall may contain the radiopaque and/or echogenic material.
  • the balloon includes a layer containing the radiopaque and/or echogenic material(s) and a layer containing a sleeve/ reinforcing member.
  • the sleeve/reinforcing member itself is echogenic.
  • the balloon wall may include at least two layers, one of which is formed from a polymer incorporating the radiopaque and/or echogenic material, while the other layer is formed from a polymer which may incorporate a sleeve/ reinforcing member.
  • the layer containing the radiopaque and/or echogenic material(s) may be positioned within or outside the layer including the sleeve/reinforcing member.
  • the balloon does not include a sleeve/reinforcing member.
  • the radiopaque and/or echogenic material is one or more of: tungsten, gold, silver, carbon, platinum, palladium, barium or bismuth. Barium and bismuth are radiopaque; whereas tungsten, gold, platinum and palladium are both radiopaque and echogenic.
  • Other echogenic materials include PVC and fluorpolymers. These materials can provide good radiopacity, and/or echogenicity, and are biocompatible.
  • the radiopaque and/or echogenic material(s) may be in the form of powder, granules, pellets or fragments dispersed throughout the layer. Tungsten is the most preferred material as this material has very good performance even when used in small amounts. Materials which are solely echogenic can be seen by fluoroscopy techniques.
  • the balloon layer containing the radiopaque/echogenic material(s) can include between 50 and 90% or between 60 and 80% or between 65 and 85% or between 75 and 85% by weight of radiopaque/echogenic material(s).
  • the layer incorporating the radiopaque/echogenic material(s) is unable to withstand the levels of inflation pressure to which the balloon is subjected to during its medical use.
  • a second layer, without the radiopaque/echogenic material(s) is included to provide support during inflation and use of the balloon.
  • One embodiment provides a balloon having two layers.
  • the outer layer is formed from a polymer material including a reinforcing member at least partially incorporated within while the inner layer is formed from a polymer material containing tungsten.
  • the balloon may be formed using the molding process described above.
  • the raw tubing may be a coextruded tubing including a layer incorporating tungsten and a layer without tungsten.
  • two separate layers of raw tubing, one positioned within the other are used in the molding process. One of these raw tubing layers incorporates tungsten while the other does not.
  • Figures 5 A-C illustrate three alternative embodiments of the distal portion of a tipless balloon catheter. These embodiments differ in the shape of the distal and proximal end portions of the catheter balloon.
  • both the distal end 510 and the proximal end 520 of the balloon 500 have a flattened profile.
  • the ends of the inflatable balloon have a generally flat surface perpendicular to a longitudinal (proximal-distal) axis of the inflatable balloon.
  • Figure 5 B illustrates an embodiment, also according to the present invention, in which the distal end 510 of the catheter balloon has a flattened profile while the proximal end 520 of the balloon has a rounded or substantially conical profile.
  • Figure 5 C illustrates an embodiment, not according to the present invention, in which the proximal end 520 and distal end 510 of the balloon have a rounded or substantially conical profile.
  • the distal end of the catheter balloon is shaped such that, when fully inflated, at least 70, 75, 80, 85, 90, 97, 98 or 99 percentage of the distal surface of the catheter balloon is positioned perpendicular to the longitudinal axis of the catheter balloon such that, when the inflated balloon is positioned against a flat surface perpendicular to the longitudinal axis of the balloon catheter, the percentages of the distal surface of the catheter balloon listed above are in contact with the flat surface.
  • FIGS. 1 and 5 may include a wire guide lumen that extends along the entire length of the catheter from the proximal end to the distal end, it is understood that the present embodiments may also include alternative lumen configurations.
  • the wire guide lumen may extend along only a portion of the length of the catheter.
  • over-the-wire, rapid exchange, short wire and intraductal exchange type delivery systems are contemplated and considered to be within the scope of the invention.
  • a rapid exchange balloon catheter includes a proximal port for the wire guide lumen that is not located at or near the proximal end of the catheter shaft. It is instead located at an intermediate location along the catheter shaft. Examples of such alternative lumen configurations are illustrated in U.S. Publication Numbers 2011/0160834 (to Aggerholm ) and 2009/0149808 (to Hansen and Aggerholm ).
  • FIG. 3 A-C and the flow diagram shown in Figure 4 illustrate one such method of manufacturing such a balloon catheter.
  • Figure 3 A illustrates an inflatable balloon 315 having a proximal end opening 330, a distal end opening 340 and a center portion 320.
  • the balloon is manufactured using a blow molding process including heating a material, such as a resin, within a mold to produce the balloon.
  • the material may be heated via heaters or viscous dissipation, e.g., working of the material through the molding process, or any other suitable means for heating the material.
  • Any polymer suitable for blow molding may also be used.
  • balloon catheter shaft 350 is inserted through proximal opening 350 and advanced so that its distal end 350 is positioned proximally of distal opening 340.
  • the proximal opening 330 of balloon 315 is then sealed to catheter shaft 350.
  • the balloon may be attached by being hot melted, adhesively bonded or solvent fused to the catheter shaft 350. Any other suitable means known to those skilled in the art may also be used to attach the balloon to the shaft.
  • FIG. 3 C shows the balloon catheter after this step is accomplished.
  • the balloon is shown to include folded region 360, which accommodate the excess longitudinal dimension of the balloon.
  • the method includes the steps of positioning a distal end of the catheter shaft of a balloon catheter at an occluded or narrowed portion of the vessel and inflating the inflatable balloon by pumping saline or another inflation medium into the interior of the balloon. Upon inflation, the distal region of the inflatable balloon moves distally against the occluded region of the vessel and pushes against the occlusion and also against the vessel wall immediately adjacent to the obstruction.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (15)

  1. Ballonkatheter, umfassend:
    einen aufblähbaren Ballon (104) mit einer entfalteten Längsabmessung und umfassend ein proximales Ende, einen mittleren Bereich, ein distales Ende und eine Längsachse, die von dem proximalen Ende zu dem distalen Ende verläuft, wobei der aufblähbare Ballon ein wenig nachgiebiger oder nicht nachgiebiger Ballon ist, und
    einen Katheterschaft (102) mit einem distalen Ende, wobei das distale Ende des aufblähbaren Ballons an dem distalen Ende des Katheters befestigt ist und wobei das proximale Ende des aufblähbaren Ballons in einem Abstand von dem distalen Ende des aufblähbaren Ballons, der kleiner als die entfaltete Längsabmessung des aufblähbaren Ballons ist, an dem Katheterschaft befestigt ist;
    dadurch gekennzeichnet, dass der aufblähbare Ballon so geformt ist, dass, wenn vollständig aufgebläht, wenigstens 80 Prozent der Oberfläche des distalen Endes senkrecht zu der Längsachse angeordnet sind.
  2. Ballonkatheter gemäß Anspruch 1, wobei der Ballon, wenn entleert, in Längsrichtung komprimiert ist.
  3. Ballonkatheter gemäß Anspruch 1, wobei der distale Bereich des Ballons bei Aufblähen distal über das distale Ende des Katheters hinausragt.
  4. Ballonkatheter gemäß Anspruch 1, wobei der Katheterschaft ein Aufblählumen umfasst, das von seinem proximalen Ende zu dem distalen Ende verläuft und in Fluidkontakt mit einem Innenraum des aufblähbaren Ballons steht.
  5. Ballonkatheter gemäß Anspruch 4, wobei der Katheterschaft ferner ein zweites Lumen umfasst, wobei das zweite Lumen dafür bemessen ist, einen Führungsdraht aufzunehmen.
  6. Ballonkatheter gemäß Anspruch 1, wobei das distale Ende des aufblähbaren Ballons eine allgemein flache Oberfläche senkrecht zu der Längsachse des aufblähbaren Ballons umfasst.
  7. Ballonkatheter gemäß Anspruch 1, wobei der Katheterschaft einen strahlenundurchlässigen Marker umfasst.
  8. Ballonkatheter gemäß Anspruch 1, wobei der aufblähbare Ballon ein Nylon umfasst.
  9. Ballonkatheter gemäß Anspruch 1, wobei der aufblähbare Ballon ein nicht nachgiebiger Ballon ist.
  10. Ballonkatheter gemäß Anspruch 1, wobei der Ballon ein Material ausgewählt aus der Gruppe bestehend aus einem strahlenundurchlässigen Material, einem echogenen Material und einer Kombination davon umfasst.
  11. Ballonkatheter gemäß Anspruch 10, wobei das Material in einer Wand des Ballons enthalten ist.
  12. Ballonkatheter gemäß Anspruch 1, wobei der Ballon ein verstärkter Ballon ist.
  13. Ballonkatheter gemäß Anspruch 1, wobei die Wand des Ballons eine Schicht umfasst, die Wolfram umfasst, und eine Schicht, die ein Verstärkungsmaterial umfasst.
  14. Verfahren zur Herstellung eines Ballonkatheters, umfassend:
    Einführen eines distalen Endes eines Katheterschafts in ein proximales Ende eines aufblähbaren Ballons, wobei der aufblähbare Ballon das proximale Ende, einen mittleren Bereich, ein distales Ende und eine Längsachse, die von dem proximalen Ende zu dem distalen Ende verläuft, umfasst, wobei der aufblähbare Ballon ein wenig nachgiebiger oder nicht nachgiebiger Ballon ist und wobei der aufblähbare Ballon so geformt ist, dass, wenn vollständig aufgebläht, wenigstens 80 Prozent der Oberfläche des distalen Endes senkrecht zu der Längsachse angeordnet sind,
    Vorschieben des distalen Endes des Katheterschafts in Richtung auf das distale Ende des aufblähbaren Ballons bis zu einer Position proximal bezogen auf das distale Ende des aufblähbaren Ballons,
    Befestigen des proximalen Endes des aufblähbaren Ballons an dem Katheterschaft, während das distale Ende des Katheterschafts an der Position proximal bezogen auf das distale Ende des aufblähbaren Ballons gehalten wird, und Befestigen des distalen Endes des aufblähbaren Ballons an dem distalen Ende des Katheterschafts, wodurch der mittlere Bereich des aufblähbaren Ballons entlang einer distal-proximal-Achse komprimiert wird.
  15. Verfahren gemäß Anspruch 14, wobei die Kompression so ist, dass sich, wenn der aufblähbare Ballon aufgebläht wird, ein distaler Bereich des aufblähbaren Ballons distal bis zu wenigstens dem distalen Ende des Katheterschafts oder über das distale Ende des Katheterschafts hinaus bewegt.
EP14705255.9A 2013-02-26 2014-01-30 Ballonkatheter Active EP2961463B1 (de)

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US201361769322P 2013-02-26 2013-02-26
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PCT/US2014/013851 WO2014133708A1 (en) 2013-02-26 2014-01-30 Balloon catheter

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